NATCO Pharma's Active Pharmaceutical Ingredient (API) facility located in Mekaguda, near Hyderabad, has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA).
The inspection was conducted by the U.S. FDA from June 9 to June 13, 2025. During the inspection, the facility received a single observation under Form 483, which was categorized as “Voluntary Action Indicated” (VAI), a classification that signifies the issues noted are not considered significant enough to warrant further regulatory action.
The issuance of the EIR on July 24, 2025, marks the formal closure of the inspection process. NATCO stated that it has already addressed the observation and remains committed to maintaining the highest standards of compliance and quality across its operations.
This positive development reinforces NATCO’s reputation in the global pharmaceutical industry and strengthens its ability to continue supplying key ingredients for various therapeutic areas to the U.S. market.
NATCO Pharma is a vertically integrated and R&D-focused pharmaceutical company engaged in developing, manufacturing, and marketing finished dosage formulations and active pharmaceutical ingredients, primarily for niche and complex therapeutic areas.
